Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Duke University

Summary

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Eligibility

Age range: 0–20 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: 1. Participant is \< 21 years of age 2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA: 3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment Exclusion Criteria: 1. Participant has a known pregnancy Below exclusion criteria apply only to: Participants receiving one or more of the study drugs of intere…

Interventions

Drug
The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.

Locations (52)

Phoenix Children's Hospital
Phoenix, Arizona
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas
University of California, Los Angeles Medical Center
Los Angeles, California
Lucile Packard Children's Hospital
Palo Alto, California
yasinour@stanford.edu 650-724-4548
Colorado University Denver
Aurora, Colorado
The Children's Hospital Colorado
Aurora, Colorado